Xibrom 0.09% and 0.18% formulations "nearly identical"

Article

A clinical trial of Xibrom (bromfenac sodium ophthalmic solution; ISTA Pharmaceuticals) has demonstrated equivalence of end-point achievement between the 0.18% and the 0.09% formulations, according to topline results published by ISTA Pharmaceuticals.

A clinical trial of Xibrom (bromfenac sodium ophthalmic solution; ISTA Pharmaceuticals) has demonstrated equivalence of end-point achievement between the 0.18% and the 0.09% formulations, according to topline results published by ISTA Pharmaceuticals.

The trial - conducted by ISTA in conjunction with the company's new drug application (NDA) for Xibrom QD (once-daily), submitted to the FDA in December 2007 - measured post-surgical absence of ocular inflammation. The 0.18% formulation is a new formulation of ISTA's ocular, non-steroidal anti-inflammatory agent (NSAID), FDA-approved in 2005 as a twice-daily treatment for inflammation and reduction of pain following cataract surgery.

The trial demonstrated nearly identical performance between the two formulations, suggesting that the 0.09% formulation may be closer to the peak of the dose-response curve than ISTA had previously suspected.

Following the study, the United States Attorney's Office of Buffalo (NY) has issued ISTA with a subpoena requesting documentation relating to promotional, educational and other activities concerning Xibrom 0.09%. ISTA has announced that it will co-operate fully with the subpoena, and will now discuss the implications of these results, including the possibility of changing the label of Xibrom 0.09% to once-daily, with the FDA.

As well as demonstrating equivalence between formulations of absence of ocular inflammation 15 days post-surgery, the trial findings also demonstrated no statistically significant difference between formulations in eliminating ocular pain and reducing inflammation. Both formulations were associated with a low incidence of adverse events.

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium
Robert Sergott, MD, describes fluorescence lifetime imaging ophthalmoscopy (FLIO) and the International SPECTRALIS Symposium – And Beyond (ISS) in Heidelberg, Germany.
Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with Ophthalmology Times Europe about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma" at the International SPECTRALIS Sympsoium. In conversation with Hattie Hayes, Ophthalmology Times Europe
Anat Loewenstein, MD, describes her presentation on remote imaging for age-related macular degeneration and geographic atrophy at the International SPECTRALIS Symposium, in conversation with Hattie Hayes of Ophthalmology Times Europe
Tyson Brunstetter, OD, PhD, a US Navy Aerospace Optometrist at the NASA Johnson Space Center in Houston, Texas, shares key takeaways from his keynote at the International SPECTRALIS Symposium (ISS)
Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium
At the Retina World Congress, Siegfried Priglinger, MD, speaks about ensuring the best outcomes for preschool-aged patients
At the 2025 ASCRS meeting, Robert Ang, MD said small aperture IOLs can benefit all patients, especially those with complex corneas or who have undergone previous corneal refractive surgery
Viha Vig, MBChB graduate student at the University of Auckland, New Zealand, discusses her poster presentation on the relationship between mitochondiral disease, Alzheimer disease, and other types of dementia.
Alfredo Sadun, MD, PhD, chief of Ophthalmology at the Doheny Eye Institute, University of California Los Angeles, shared exciting new research with the Eye Care Network during the Association for Research in Vision and Ophthalmology (ARVO) meeting on the subject of Leber hereditary optic neuropathy (LHON).
© 2025 MJH Life Sciences

All rights reserved.